Hemopure® to be evaluated in groundbreaking clinical study of trauma patients in the prehospital setting, sponsored by the United States Department of Defense, and coordinated by Stellenbosch University

November 8, 2018

Patient enrollment expected to commence in mid 2019

Hemopure, the Company’s oxygen carrying solution, could potentially be an integral part of trauma resuscitation practice in remote locations

SOUDERTON, Pa., Nov. 8, 2018 /PRNewswire/ — Hemoglobin Oxygen Therapeutics LLC (HbO2 Therapeutics), a private biopharmaceutical company specializing in oxygen therapeutics (previously known as “blood substitutes”) for both human and veterinary use, today announced the signing of an $8.2 million contract between the U.S. Department of Defense and the University of Stellenbosch (Cape Town, South Africa). The University will coordinate a clinical trial across 21 South African hospitals and 27 ambulance bases. The trial will evaluate prehospital use of Hemopure® (HbO2 Therapeutics) in conjunction with freeze-dried plasma, BioPlasma® FDP (National Biologics Institute). HbO2 Therapeutics will supply Hemopure for the study, expected to enroll at least 1,400 patients over 3 years. Hemopure is a chemically stabilized bovine hemoglobin that was developed for use in humans as an oxygen delivery “bridge” in situations when blood is not immediately available or not an option.

The use of Hemopure and BioPlasma FDP would be the closest alternative to whole blood when the latter is not an option. If successful, the study could lead to major advancements in trauma care in South Africa and other locations where Hemopure and BioPlasma FDP are available.

“The time it takes to transport patients from an accident scene to the hospital is relatively short in an urban setting. In more rural areas or on the battlefield it can take hours, significantly increasing morality rates,” said Zafiris Zafirelis, CEO of HbO2 Therapeutics. “We are thrilled that Hemopure was selected to be a part of this study. In patients for whom blood transfusions are not available or not an option, access to Hemopure has the potential to save lives”. Zafirelis continued, “The focus of this study is hemorrhagic shock, a leading cause of preventable death after severe trauma in both civilian and military settlings. Mortality from hemorrhage represents a significant problem worldwide, with an estimated 1.9 million deaths per year, globally, of which 1.5 million results from trauma. The South African Medicines Control Council approved Hemopure in 2001 for the treatment of anemia in adult surgical patients”.

“In most countries around the world, the standard of care for resuscitation of patients who are bleeding prior to arrival at hospital is a saline solution,” says Professor Lee Wallis, Head of the Division of Emergency Medicine at Stellenbosch University. “Since saline does not carry oxygen nor the coagulation factors essential for blood clotting, use of an oxygen carrier such as Hemopure and a freeze-dried plasma, can potentially make the difference between life and death, by providing a lifesaving bridge to enable patients to get to a hospital where they can get blood products and surgery” added Wallis.

About Hemoglobin Oxygen Therapeutics LLC

HbO2 Therapeutics is a leading developer and manufacturer of oxygen carrying solutions, a class of drug products that when administered intravenously can increase the amount of oxygen transported throughout the body. The company has developed two products: Hemopure (hemoglobin glutamer – 250 (bovine)) and Oxyglobin® [hemoglobin glutamer – 200 (bovine)], for human and veterinary use, respectively.

Hemopure is approved in South Africa to treat anemia in adult surgical patients, and in the Russian Federation for acute anemia, irrespective of etiology. Hemopure is not approved in the US, and only available through the FDA expanded access program to qualifying patients with severe, life threatening anemia for whom blood transfusion is not an option, and who have exhausted all other treatment options. Blood transfusion may not be an option due to religious beliefs, or because no compatible blood is available for a patient needing transfusion. Hemopure is also under development for other uses, including as a perfusion solution for organs prior to transplantation.

Oxyglobin is the only oxygen carrying solution approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to treat all cause canine anemia.

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